Fintech
Shining a Light on Soligenix’s HyBryte(TM) Growth Opportunity
Company Connecting the Dots for Final FDA Approval
New York, New York–(Newsfile Corp. – June 3, 2021) – PCG Digital — When Soligenix (NASDAQ: SNGX) updated its NDA rollout plan, the market quickly reacted. While the timeline was adjusted, the big picture and ultimate end game remain the same. With conditional acceptance of the HyBryteTM name by the FDA and positive news in Japan and the UK, Soligenix continues to move forward in its aim to treat cutaneous T cell lymphoma.
Soligenix is developing SGX301 (recently branded HyBryteTM) for the treatment of cutaneous T cell lymphoma (CTCL) and has successfully completed its Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial and a rolling NDA was expected to start this quarter.
On May 7th, the company announced that due to manufacturing issues caused in part by the ongoing pandemic and following FDA discussions, it would not pursue a “rolling” NDA at this time, but would instead submit it in the first half of 2022 with corresponding potential FDA approval adjusted to the first half of 2023. At first glance, this may appear as a major delay, however even with a rolling NDA the final module would not have been submitted until the first half of 2022 with FDA approval in late 2022. In reality, the potential delay is likely to be brief with FDA approval now expected in the first half of 2023 instead of late 2022.
HyBryteTM, the commercial name for SGX301 (synthetic hypericin), was recently recognized by the American Academy of Dermatology as “Top 12 Late-Breaking Research.” Clinical studies have indicated it will be an effective therapy for early stage cutaneous T-cell lymphoma (CTCL), which makes up the vast majority of the patient population living with this disease.
HyBryteTM Brand Name Conditionally Accepted by FDA
On an even more positive note, Soligenix is already planning for the commercialization of HyBryteTM. According to the Company’s recent release, HyBryteTM is now locked in as the brand name for SGX301.
“We received U.S. Food and Drug Administration (FDA) conditional acceptance of HyBryte™ as the proposed brand name for SGX301 (synthetic hypericin),” CEO Dr. Christopher J. Schaber reported. “We continue to prepare for a new drug application (NDA) submission.”
There are roughly three thousand new cases of CTCL in the U.S. each year and another approximate 20,000 patients living with CTCL in the U.S. It’s a rare form of non-Hodgkin’s lymphoma, allowing the FDA to classify HyBryteTM as an orphan drug, putting it on the fast track for approval when the time comes.
Soligenix has the available cash and resources to market HyBryteTM in the US without the assistance of outside partners, so there’s no danger of losing funding by delaying the rolling NDA. Marketing and sales processes are already underway for when FDA approval is granted.
“With approximately $30 million in cash, not including our non-dilutive government funding, we anticipate having sufficient capital to achieve multiple inflection points as we advance our rare disease pipeline, including NDA filing and U.S. commercialization of HyBryte™ in CTCL, where we estimate peak U.S. annual net sales to exceed $90 million and the total U.S. revenues during the 10-year forecast period to be greater than $700 million,” Dr. Schaber added.
Patented in Japan and Awarded an “Innovation Passport” in the UK
To further solidify the marketability of HyBryteTM, Soligenix was recently approved for a patent in Japan titled “Systems and Methods for Producing Synthetic Hypericin.” Synthetic hypericin is the active pharmaceutical ingredient in HyBryteTM.
One week prior to that patent approval, the company was awarded an “innovation passport” in the United Kingdom to treat early stage CTCL patients who fall under their Innovative Licensing and Access Pathway (ILAP) program. ILAP was launched earlier in 2021.
Combine these two events with the positive results from the recent FLASH (fluorescent light activated synthetic hypericin) trial, and the table is set for potential success in the next year and a half. Peak US annual net sales are estimated to exceed $90 million.
Zack’s Issues Updated Valuation for Soligenix (SNGX)
On May 24th, Dr. David Bautz at Zack’s Small-Cap Research, issued an updated SNGX valuation which was positively received by investors, with the stock opening up higher on increasing volume.
Here is a link to Dr. Bautz’s report: https://finance.yahoo.com/news/sngx-hybryte-conditionally-accepted-proprietary-115000575.html
“Soligenix has a strong balance sheet and there will be little to no budgetary impact caused by the change of the NDA submission,” Dr. Bautz stated in the report. “We were surprised at the change in timeline, but it does not appear there will be too much of a delay in FDA approval.”
A Potentially Bright Future for Soligenix’s HyBryte
This Zacks valuation update is noticeable. Investors may recall that the company’s pre-pandemic share price peaked at $3.16 and over the past 12 months, Soligenix has made great strides and is now equipped with a strong war chest of over $30 million to push forward on multiple fronts. The future is bright.
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As we close out 2024, the fintech industry continues to deliver headlines that underscore its dynamism and innovation. From IPO aspirations to groundbreaking regulatory milestones, today’s updates highlight the transformative power of fintech partnerships, regulatory evolution, and disruptive technologies. Here’s what you need to know.
Chime’s Quiet Step Toward Public Markets
Chime, the U.S.-based financial technology startup best known for its digital banking services, has taken a significant step by filing confidential paperwork for an initial public offering (IPO). As one of the most valuable private fintechs in the U.S., Chime’s move could potentially signal a renewed appetite for fintech IPOs in a market that has been cautious following fluctuating valuations across the tech sector.
With a valuation that reportedly exceeded $25 billion in its last funding round, Chime’s IPO could set a new benchmark for the industry. Observers note that its strong customer base and revenue growth may make it an appealing choice for investors seeking to capitalize on the digital banking boom. However, the timing and success of the IPO will depend on broader market conditions and the regulatory landscape.
Source: Bloomberg
ZBD’s Pioneering Achievement: EU MiCA License Approval
ZBD, a fintech company specializing in Bitcoin Lightning network solutions, has made history by becoming the first to secure an EU MiCA (Markets in Crypto-Assets Regulation) license. This landmark approval by the Dutch regulator positions ZBD at the forefront of compliant crypto-fintech operations in Europe.
MiCA, which aims to harmonize the regulatory framework for crypto-assets across the EU, has been a focal point for industry players aiming to establish legitimacy and expand their offerings. ZBD’s achievement not only validates its operational rigor but also sets a precedent for other fintech firms navigating the evolving regulatory landscape.
Industry insiders view this as a strategic advantage for ZBD as it broadens its footprint in Europe. By leveraging its regulatory approval, the company can accelerate its product deployment and establish trust with institutional and retail users alike.
Source: Coindesk, PR Newswire
The Fintech-Credit Union Synergy: A Blueprint for Innovation
The convergence of fintechs and credit unions continues to reshape the financial services ecosystem. Collaborative initiatives, such as the one highlighted in the recent partnership between fintech innovators and credit unions, are proving to be a potent force in delivering tailored financial solutions.
This “dream team” approach allows credit unions to leverage fintech’s technological expertise while maintaining their community-focused ethos. Key areas of collaboration include digital payments, personalized financial management tools, and enhanced loan processing capabilities. These partnerships not only enhance member engagement but also enable credit unions to remain competitive in an increasingly digital-first financial environment.
Industry analysts emphasize that such collaborations underscore a broader trend of traditional financial institutions embracing fintech-driven solutions to bridge service gaps and foster innovation.
Source: PYMNTS
Tackling Student Loan Debt: A Fintech’s Mission
Student loan debt remains a pressing issue for millions of Americans, and a Rochester-based fintech aims to offer relief through its cloud-based platform. This innovative solution is designed to simplify loan management and provide borrowers with actionable insights to reduce their debt burden.
The platform’s features include repayment optimization tools, personalized financial education, and seamless integration with loan servicers. By addressing the complexities of student loan management, this fintech is empowering borrowers to make informed decisions and achieve financial stability.
As the student loan crisis continues to evolve, solutions like this highlight the critical role fintech can play in addressing systemic financial challenges while fostering financial literacy and inclusion.
Source: RBJ
Industry Implications and Takeaways
Today’s updates underscore several key themes shaping the fintech landscape:
- Regulatory Milestones: ZBD’s MiCA license approval exemplifies the importance of regulatory compliance in unlocking growth opportunities.
- Strategic Partnerships: The collaboration between fintechs and credit unions demonstrates the value of combining technological innovation with traditional financial models to drive customer-centric solutions.
- Market Opportunities: Chime’s IPO move reflects a potential revival in fintech public offerings, signaling confidence in the sector’s long-term prospects.
- Social Impact: Fintech’s ability to tackle systemic issues, such as student loan debt, showcases its role as a force for positive change.
The post Fintech Pulse: Your Daily Industry Brief (Chime, ZBD, MiCA) appeared first on News, Events, Advertising Options.
Leading global payments platform SPAYZ.io has confirmed it will be attending iFX EXPO Dubai 2025 on 14 to 16 January. Exhibiting at Stand 64 at Trade Centre Dubai, SPAYZ.io’s team of professionals will be on hand providing live demonstrations of its renowned payment services for payment providers. Attendees will also receive exclusive insight into SPAYZ.io’s plans for 2025 alongside early early access to its upcoming plans for the new year.
SPAYZ.io delivers a host of payment solutions that leverage the latest technological innovations and open access to the fastest growing emerging markets across Africa, Europe and Asia. Over the past year, there has been huge demand for its Open Banking and local payment method services, alongside bank transfers, mass payouts, online banking and e-wallets.
Yana Thakurta, Head of Business Development at SPAYZ.io commented: “We look forward to once again participating at iFX Dubai to expand our network of partners and clients. It’s a fantastic way to kick off the year, connecting with thousands of industry leaders from FOREX platforms to trading companies, and everything in between.
“Our key goal for iFX Dubai EXPO 2025 is to expand our portfolio of solutions and geographies. We’re using this as an opportunity to partner with like-minded entities who share our ambition to provide payment solutions that are truly global.”
Come meet SPAYZ.io’s team at the Trade Centre Dubai at Stand 64. You can also book a meeting slot with a member of a team.
The post SPAYZ.io prepares for iFX EXPO Dubai 2025 appeared first on News, Events, Advertising Options.
Airtm, the most connected digital dollar account in the world, is proud to announce the addition of two distinguished industry leaders to its Board of Directors: Rafael de la Vega, Global SVP of Partnerships at Auctane, and Shivani Siroya, CEO & Founder of Tala. These appointments reflect Airtm’s commitment to innovation and financial inclusion as the company enters its next phase of growth.
“We are thrilled to welcome Rafael and Shivani to Airtm’s Board of Directors,” said Ruben Galindo Steckel, Co-founder and CEO of Airtm. “Their unique perspectives and proven track records will be invaluable as we continue scaling our platform to empower individuals and businesses in emerging markets. Together, we’ll push the boundaries of financial inclusion and innovation to create a more connected and equitable global economy. Rafael and Shivani bring a wealth of experience and strategic insight that will strengthen Airtm’s mission to connect emerging economies with the global market.”
Rafael de la Vega, a seasoned leader in fintech global partnerships and technology innovation, is currently the Global SVP of Partnerships at Auctane. With a proven track record of delivering scalable, impactful solutions at the intersection of fintech, innovation, and commerce, Rafael’s expertise will be pivotal as Airtm continues to grow. “Airtm has built a platform that breaks down barriers and opens up opportunities for people in emerging economies to connect to global markets. I am excited to contribute to its growth and help further its mission of fostering financial inclusion on a global scale,” said Rafael.
Shivani Siroya, CEO and Founder of Tala, is a pioneer in financial technology, renowned for empowering underserved communities through access to credit and essential financial tools. Her leadership in leveraging data-driven innovation aligns seamlessly with Airtm’s vision of creating more equitable financial opportunities. “Empowering underserved communities has always been at the core of my work, and Airtm’s mission resonates deeply with me. I’m thrilled to join the Board and work alongside such a dynamic team to expand access to financial tools that truly make a difference in people’s lives,” said Shivani.
The post Airtm Enhances Its Board of Directors with Two Strategic Appointments appeared first on News, Events, Advertising Options.
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